RAPS AnnouncementsRAPS Announcements
RAPS' LatestRAPS' Latest
RAPS congratulates 82 professionals for earning RAC certification
Posted 10 October 2022 By Nicole Duran
RAPS congratulates the 82 professionals who earned their Regulatory Affairs Certification (RAC) during the summer examination window. The RAC credential is the leading certification for regulatory professionals in the healthcare product ...
RAPS AnnouncementsRAPS Announcements
RAPS' LatestRAPS' Latest
Why these 5 regulatory professionals can’t wait for RAPS Convergence 2022
Posted 23 August 2022 By Ryan Connors
After two years of virtual conferences, the premier regulatory affairs gathering is once again a live event. 
RAPS' LatestRAPS' Latest
RAPS AnnouncementsRAPS Announcements
RAPS announces the 2022 Fellows Program recipients
Posted 17 August 2022 By Ryan Connors
The Regulatory Affairs Professionals Society (RAPS) has named 10 exceptional senior regulatory professionals to the distinguished ranks of the RAPS Fellows Program.
RAPS' LatestRAPS' Latest
RAPS AnnouncementsRAPS Announcements
What it’s like to present a poster at Euro Convergence, with Raquel Carnero
Posted 08 July 2022 By Ryan Connors
Delegates submitted a record-breaking 20 posters for Euro Convergence 2022. Raquel Carnero’s submission, “Regulatory intelligence, to protect and to serve your medical device strategy in the world” took home the top prize.
Regulatory NewsRegulatory News
ICH details milestones reached on guidelines after Athens meeting
Posted 02 June 2022 By Joanne S. Eglovitch
The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for testing pharmaceuticals and extrapolating adult clin...
Feature ArticlesFeature Articles
April’s Regulatory Focus: Specialist vs. generalist, RI, and more
Posted 06 May 2022 By Renee Matthews
Feature articles during April examined the roles of the regulatory specialist and generalist and the application of regulatory intelligence (RI) in managing the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), developing an ...
Feature ArticlesFeature Articles
September’s Regulatory Focus: Diversity in regulatory affairs, clinical trials, and more
Posted 07 October 2021 By Renee Matthews
Feature articles during September focused on diversity in regulatory affairs, challenges in conducting medical device clinical trials in Europe, clinical trial regulation and laws in China, and risk management in working with third-party...
ReconRecon
Recon: FDA vax approval signals looming mandates; Pfizer's $2.3B Trillium takeover
Posted 23 August 2021 By Kari Oakes
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: $26B Opioids lawsuit deal imminent; Amylyx closes $135M ALS financing deal
Posted 20 July 2021 By Kari Oakes
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
EC issues first COVID therapeutics portfolio
Posted 29 June 2021 By Kari Oakes
“Today we are taking the first step towards a broad portfolio of therapeutics to treat COVID-19,” said Stella Kyriakides, EC’s Commissioner for Health and Food Safety. “Whilst vaccination is progressing at increasing speed, the virus wil...
Virtual ProgramsVirtual Programs
Business Writing for Regulatory Professionals: Making It Easy (Feb 2023)
Wednesday, 15 February 2023 (1:00 - 3:00PM) 2.0 RAC Credits Member: $230 | NonMember: $270
Learn to write documents in a clear and well‐organized manner under short deadlines, that are correct, complete and concise.
Virtual ProgramsVirtual Programs
Strategies in Meetings: Achieving Your Objectives (Mar 2023)
Wednesday, 01 March 2023 (1:00 - 3:00PM) 2.0 RAC Credits Member: $230 | NonMember: $270
Discover ten techniques that will improve your ability to persuade others to pursue a course of action.
Virtual ProgramsVirtual Programs
Conflict Resolution and Negotiation: Effective Tools and Techniques (Mar 2023)
Wednesday, 15 March 2023 (1:00 - 3:00PM) 2.0 RAC Credits Member: $230| NonMember: $270
Become a more effective communicator by enhancing your conflict resolution and negotiation skills.
In-PersonIn-Person
Executive Development Program at the Kellogg School of Management
Sunday, 07 May 2023 (9:00 - 4:00PM) 12.0 RAC Credits The only leadership program dedicated to regulatory professionals like you that combines regulatory experts with faculty from one of the most prestigious business schools in the US, the Kellogg School of Management at Northwestern University.
Virtual ProgramsVirtual Programs
Preparing to Take the RAC Drugs Exam (May 2023)
Wednesday, 31 May 2023 (11:00 - 4:00PM) 12.0 RAC Credits Member: $495 | NonMember: $580
Designed specifically for those preparing to take the RAC Drugs exam. This workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
Virtual ProgramsVirtual Programs
Software as a Medical Device (SaMD) (June 2023)
Wednesday, 14 June 2023 (9:00 - 4:00PM) 12.0 RAC Credits Member $970 | Non-Member $1150
Join us for a review of the current and evolving global regulatory requirements affecting software as a medical device (SaMD).
Virtual ProgramsVirtual Programs
Cybersecurity Unauthorized (Feb 2023)
Tuesday, 07 February 2023 (9:00 - 4:00PM) 12.0 RAC Credits Members: $970 | Nonmembers: $1,150
This workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations.
Virtual ProgramsVirtual Programs
The Evolving Regulatory Landscape in Oncology Drug Development
Thursday, 23 March 2023 (12:00 - 1:30PM) 1.5 RAC Credits Member: $175 | Nonmember: $200 This webcast will provide an overview of three recent initiatives from the Oncology Center of Excellence, as well as some in-depth discussions with several key opinion leaders.
In-PersonIn-Person
Software as a Medical Device
Tuesday, 18 April 2023 (9:00 - 4:00PM) 12.0 RAC Credits Members: $1,340 | Nonmembers: $1,570
In this two-day, in-person workshop, regulatory experts will review current and evolving regulatory requirements for software as a medical device to navigate the challenging expectations for software.
In-PersonIn-Person
MedCon 2023
Monday, 24 April 2023 (9:30 - 4:00PM) 0.0 RAC Credits For 13+ years, MedCon has united the healthcare products industry to work for a better tomorrow for our patients. MedCon 2023 is hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by Food and Drug Administration (FDA).
Virtual ProgramsVirtual Programs
Considerations in Preparing for an FDA PAI or BIMO Inspection
Wednesday, 29 March 2023 (12:00 - 1:30PM) 1.5 RAC Credits Member: $175 | NonMember: $200
This webcast will provide a thorough understanding of how to prepare for an FDA PAI or BIMO inspection, including Inspection Readiness plans, Gap Analysis and Remediation, and Inspection Logistics.
Virtual ProgramsVirtual Programs
REC Webinar: Spotlight on EU Food Regulations
Monday, 27 February 2023 (6:00 - 7:30PM) 1.5 RAC Credits Member: €‎ 0 | €‎ 25
This webcast will provide insights into responsible food research & innovation and the role of regulations in EU, including novel food & health claim requirements.
     
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Books   |   Learning

BooksBooks
Introduction to the Due Diligence Process, Second Edition
Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
On-demandOn-demand
Sponsored Webcast: What is FDA's Project Optimus and How Will it Impact Oncology Drug Development? (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webinar will provide information on FDA’s Project Optimus and its potential impacts on oncology drug development.
On-demandOn-demand
Sponsored Webcast: eCTD Submission Challenges (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
Regulatory operations specialist Joshua Lett will explore how challenges in eCTD submissions may provide opportunities for personal and professional growth.
On-demandOn-demand
FDA QMSR: What do the Proposed Changes Mean for Industry? (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
Speakers will review the history of quality systems, look at the changes to quality regulations and discuss the FDA’s intent to adopt the ISO 13485 standard.
BooksBooks
Regulatory Writing: An Overview, Second Edition
Member: $160.00 Nonmember: $225.00
This new edition is a valuable resource for professionals engaged in designing, composing, compiling, or commenting on regulatory documentation.
BooksBooks
Eclectic Science and Regulatory Compliance: Stories for the Curious
Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
BooksBooks
Communication and Negotiation
Member: $15.00 Nonmember: $20.00
This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.
BooksBooks
Choosing the Right Regulatory Career
Member: $20.00 Nonmember: $25.00
Research the diverse and demanding career options available to regulatory professionals across the industry. From traditional and alternative career pathways, explore the many ways to break into regulatory.
Online CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Introductory Medical Writing [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides an overview of the medical writing profession from a regulatory perspective, including an introduction to the basic skills important for medical writing in that field.
On-demandOn-demand
How to Facilitate Regulatory Meetings (On-Demand)
1.5 RAC Credits
Member: $0.00 Nonmember: $25.00
This webcast will help prepare regulatory professionals for the difficult task of meeting facilitation.
Online CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Effective Regulatory Communication [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
In this course, you will obtain an understanding of the complexities and principles of regulatory communication.
Online CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Project Management for Regulatory Professionals [4.0 RAC]
4.0 RAC Credits
Member: $465 Nonmember: $640
This course provides guidance for effectively establishing a regulatory development project plan, including identifying resources and determining the effort and timing required to create project and budget reports.
     
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RAC ExamRAC Exam
RAC Devices Examination Autumn 2023
Member: $495.00 Nonmember: $625.00
Testing Window :
30 October 2023 To 8 December 2023
Registration Deadline : 5 October 2023
RAC ExamRAC Exam
RAC Devices Examination Spring 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 20 March 2023 To 28 April 2023
Registration Deadline : 23 February 2023
RAC ExamRAC Exam
RAC Devices Examination Summer 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 10 July 2023 To 18 August 2023
Registration Deadline : 15 June 2023
RAC ExamRAC Exam
RAC Drugs Examination Autumn 2023
Member: $495.00 Nonmember: $625.00
Testing Window :
30 October 2023 To 8 December 2023
Registration Deadline : 5 October 2023
RAC ExamRAC Exam
RAC Drugs Examination Spring 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 20 March 2023 To 28 April 2023
Registration Deadline : 23 February 2023
RAC ExamRAC Exam
RAC Drugs Examination Summer 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 10 July 2023 To 18 August 2023
Registration Deadline : 15 June 2023
Virtual ProgramsVirtual Programs
Software as a Medical Device (SaMD) (June 2023)
Wednesday, 14 June 2023 (9:00 - 4:00PM)
12.0RAC Credits
Member $970 | Non-Member $1150
Join us for a review of the current and evolving global regulatory requirements affecting software as a medical device (SaMD).
Virtual ProgramsVirtual Programs
Preparing to Take the RAC Drugs Exam (May 2023)
Wednesday, 31 May 2023 (11:00 - 4:00PM)
12.0RAC Credits
Member: $495 | NonMember: $580
Designed specifically for those preparing to take the RAC Drugs exam. This workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
In-PersonIn-Person
Executive Development Program at the Kellogg School of Management
Sunday, 07 May 2023 (9:00 - 4:00PM)
12.0RAC Credits
The only leadership program dedicated to regulatory professionals like you that combines regulatory experts with faculty from one of the most prestigious business schools in the US, the Kellogg School of Management at Northwestern University.
In-PersonIn-Person
MedCon 2023
Monday, 24 April 2023 (9:30 - 4:00PM)
For 13+ years, MedCon has united the healthcare products industry to work for a better tomorrow for our patients. MedCon 2023 is hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by Food and Drug Administration (FDA).
In-PersonIn-Person
Software as a Medical Device
Tuesday, 18 April 2023 (9:00 - 4:00PM)
12.0RAC Credits
Members: $1,340 | Nonmembers: $1,570
In this two-day, in-person workshop, regulatory experts will review current and evolving regulatory requirements for software as a medical device to navigate the challenging expectations for software.
Virtual ProgramsVirtual Programs
Considerations in Preparing for an FDA PAI or BIMO Inspection
Wednesday, 29 March 2023 (12:00 - 1:30PM)
1.5RAC Credits
Member: $175 | NonMember: $200
This webcast will provide a thorough understanding of how to prepare for an FDA PAI or BIMO inspection, including Inspection Readiness plans, Gap Analysis and Remediation, and Inspection Logistics.
Virtual ProgramsVirtual Programs
The Evolving Regulatory Landscape in Oncology Drug Development
Thursday, 23 March 2023 (12:00 - 1:30PM)
1.5RAC Credits
Member: $175 | Nonmember: $200 This webcast will provide an overview of three recent initiatives from the Oncology Center of Excellence, as well as some in-depth discussions with several key opinion leaders.
Virtual ProgramsVirtual Programs
Conflict Resolution and Negotiation: Effective Tools and Techniques (Mar 2023)
Wednesday, 15 March 2023 (1:00 - 3:00PM)
2.0RAC Credits
Member: $230| NonMember: $270
Become a more effective communicator by enhancing your conflict resolution and negotiation skills.
Virtual ProgramsVirtual Programs
Strategies in Meetings: Achieving Your Objectives (Mar 2023)
Wednesday, 01 March 2023 (1:00 - 3:00PM)
2.0RAC Credits
Member: $230 | NonMember: $270
Discover ten techniques that will improve your ability to persuade others to pursue a course of action.
Virtual ProgramsVirtual Programs
REC Webinar: Spotlight on EU Food Regulations
Monday, 27 February 2023 (6:00 - 7:30PM)
1.5RAC Credits
Member: €‎ 0 | €‎ 25
This webcast will provide insights into responsible food research & innovation and the role of regulations in EU, including novel food & health claim requirements.
Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
DC/ Baltimore Chapter: FDA Compliant Use of Smartphones, Apps and Technology in Clinical Trials
Wednesday, 22 February 2023 (11:00 - 12:00PM)
1.0RAC Credits
Member: $0| Nonmember: $25
Use of wearable devices and smart technology is increasing in clinical trials. This program will discuss the use of Smartphones, Apps and other technology in terms of FDA compliance and practical concerns
Virtual ProgramsVirtual Programs
Business Writing for Regulatory Professionals: Making It Easy (Feb 2023)
Wednesday, 15 February 2023 (1:00 - 3:00PM)
2.0RAC Credits
Member: $230 | NonMember: $270
Learn to write documents in a clear and well‐organized manner under short deadlines, that are correct, complete and concise.